Zydus Cadila seeks DCGI nod for use of hepatitis drug for COVID-19 treatment
Drug agency Zydus Cadila on Monday mentioned it has sought approval from the home drug regulator Drugs Controller General of India (DCGI) for the extra indication of its hepatitis drug Pegylated Interferon Alpha-2b for treating COVID-19. Phase-III scientific trials with Pegylated Interferon Alpha 2b, which the corporate sells underneath the model title ‘PegiHep’ has proven promising leads to treating COVID-19, Zydus Cadila mentioned in a press release.
The interim outcomes point out that the drug when administered early on, might assist sufferers recuperate sooner and keep away from a lot of the problems seen within the superior phases of the illness, it added.
“The treatment regimen would be less cumbersome and more affordable for patients as Pegylated Interferon Alpha 2b, is a single-dose regimen. It would also ensure better compliance,” Zydus Cadila mentioned.
PegIFN has very well-established security with a number of doses in continual Hepatitis B and C sufferers since a few years, it added.
Patients on Pegylated Interferon Alpha 2b throughout the trial additionally confirmed lesser want for supplemental oxygen, clearly indicating that it was in a position to management respiratory misery and failure which has been one of the foremost challenges in treating COVID-19, the assertion mentioned.
“With these positive results, the company has applied for an approval for additional indication with DCGI for the use of PegIFN in the treatment of COVID 19,” it added.
The phase-III trials have been performed on 250 sufferers throughout 20-25 centres in India and the detailed outcomes of this can be printed in a peer-reviewed scientific journal, the corporate mentioned.
“We are encouraged by the results of phase-III study of Pegylated Interferon Alpha 2b which has confirmed the potential to reduce virus titres when given earlier in the disease,” Cadila Healthcare MD Sharvil Patel mentioned.
With Indian Innovation on the forefront serving to the nation struggle the pandemic with diagnostics, vaccines and therapeutics, this marks an essential milestone, he added.
Besides conducting a phase-II trial in Mexico, the corporate can be working with the United States Food and Drug Administration (USFDA) for Pegylated Interferon Alpha-2b to be able to provoke applicable scientific trials within the US, the corporate mentioned.
Shares of Cadila Healthcare, the listed entity of Zydus Group, have been buying and selling at Rs 438.55 per scrip on BSE, down 0.75 per cent from its earlier shut.Â
